Analysis of Equipoise Shift in CLOTBUST-ER Has Been Published
Therapeutic Advances in Neurological Disorders has published “Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke”. This paper presents a case study of the CLOTBUST-ER trial, showing that the “increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies “. With the rise of EVT during the course of the trial, the segment of the eligible stroke population who were most likely to receive the best outcomes from sonothrombolysis were disproportionately redirected away from the trial. The paper includes a post hoc analysis suggesting that this shift negatively impacted the CLOTBUST-ER results. This analysis reinforces the importance of the improvements that Cerevast is implementing in the phase 3 TRUST study.
